DEPO-ESTRADIOL- estradiol cypionate injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ESTRADIOL CYPIONATE (UNII: 7E1DV054LO) (ESTRADIOL CYPIONATE - UNII:7E1DV054LO)

متاح من:

Physicians Total Care, Inc.

INN (الاسم الدولي):

ESTRADIOL CYPIONATE

تركيب:

ESTRADIOL CYPIONATE 5 mg in 1 mL

طريقة التعاطي:

INTRAMUSCULAR

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

DEPO-Estradiol Injection is indicated in the treatment of: - Moderate to severe vasomotor symptoms associated with the menopause. - Hypoestrogenism due to hypogonadism. Estrogens should not be used in individuals with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known or suspected cancer of the breast. - Known or suspected estrogen-dependent neoplasia. - Active deep vein thrombosis, pulmonary embolism or history of these conditions. - Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - Liver dysfunction or disease. - DEPO-Estradiol should not be used in patients with known hypersensitivity to its ingredients. - Known or suspected pregnancy. There is no indication for DEPO-Estradiol in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS.) Chlorobu

ملخص المنتج:

DEPO-Estradiol Injection is available in the following concentration containing per mL: 5 mg estradiol cypionate; also 5.4 mg chlorobutanol anhydrous (chloral deriv.) added as preservative; in 913 mg cottonseed oil— in 5 mL vials, NDC 54868-1729-0. WARNING: Chlorobutanol may be habit forming. Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DEPO-ESTRADIOL - ESTRADIOL CYPIONATE INJECTION
PHYSICIANS TOTAL CARE, INC.
----------
DEPO -ESTRADIOL
ESTRADIOL CYPIONATE INJECTION, USP
WARNINGS
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is
important. Adequate diagnostic
measures including endometrial sampling, when indicated, should be
undertaken to rule out
malignancy in all cases of undiagnosed persistent or recurring
abnormal vaginal bleeding. There
is currently no evidence that the use of "natural" estrogens results
in a different endometrial risk
profile than "synthetic" estrogens at equivalent estrogen doses. (SEE
WARNINGS, MALIGNANT
NEOPLASMS, ENDOMETRIAL CANCER.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used for the
prevention of cardiovascular
disease. (SEE WARNINGS, CARDIOVASCULAR DISORDERS.)
The Women's Health Initiative (WHI) study reported increased risks of
myocardial infarction,
stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal
women (50 to 79 years of age) during 5 years of treatment with oral
conjugated estrogens (CE
0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg)
relative to placebo. (See
CLINICAL PHARMACOLOGY, CLINICAL STUDIES.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI,
reported increased
risk of developing probable dementia in postmenopausal women 65 years
of age or older during 4
years of treatment with oral conjugated estrogens plus
medroxyprogesterone acetate relative to
placebo. It is unknown whether this finding applies to younger
postmenopausal women or to
women taking estrogen-alone therapy. (See CLINICAL PHARMACOLOGY,
CLINICAL STUDIES.)
Other doses of conjugated estrogens with medroxyprogesterone acetate,
and other combinations
and dosage forms of estrogens and progestins were not studied in the
WHI clinical trials and, in
the absence of comparable data, these risks should be assumed to be
similar. Because of these
risks, estrogens with or